Medication, published by HL7 Belgium. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-be/medication/tree/master and changes regularly. See the Directory of published versions
Official URL: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel | Version: 1.1.0 | |||
Draft as of 2025-06-27 | Computable Name: OffLabel |
Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
Context of Use
This extension may be used on the following element(s)
MedicationRequest
MedicationStatement
Usage info
Usages:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required |
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1..* | Extension | Extension | |
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Content/Rules for all slices | |||
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1..1 | Extension | Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided. | |
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0..0 | |||
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1..1 | uri | "isOffLabelUse" | |
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0..1 | boolean | Value of extension | |
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0..* | Extension | Reason or related clarification for off-label use. | |
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0..0 | |||
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1..1 | uri | "reason" | |
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0..1 | CodeableConcept | Value of extension | |
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1..1 | uri | "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel" | |
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0..0 | |||
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Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required |
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0..1 | string | Unique id for inter-element referencing | |
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |
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1..1 | Extension | Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided. | |
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0..1 | string | Unique id for inter-element referencing | |
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0..0 | |||
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1..1 | uri | "isOffLabelUse" | |
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0..1 | boolean | Value of extension | |
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0..* | Extension | Reason or related clarification for off-label use. | |
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0..1 | string | Unique id for inter-element referencing | |
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0..0 | |||
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1..1 | uri | "reason" | |
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0..1 | CodeableConcept | Value of extension | |
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1..1 | uri | "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel" | |
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This structure is derived from Extension
Summary
Complex Extension: Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
Differential View
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
![]() ![]() |
C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required |
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1..* | Extension | Extension | |
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Content/Rules for all slices | |||
![]() ![]() ![]() ![]() |
1..1 | Extension | Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided. | |
![]() ![]() ![]() ![]() ![]() |
0..0 | |||
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1..1 | uri | "isOffLabelUse" | |
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0..1 | boolean | Value of extension | |
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0..* | Extension | Reason or related clarification for off-label use. | |
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0..0 | |||
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1..1 | uri | "reason" | |
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0..1 | CodeableConcept | Value of extension | |
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1..1 | uri | "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel" | |
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0..0 | |||
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Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
---|---|---|---|---|
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C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required |
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0..1 | string | Unique id for inter-element referencing | |
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |
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1..1 | Extension | Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided. | |
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0..1 | string | Unique id for inter-element referencing | |
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0..0 | |||
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1..1 | uri | "isOffLabelUse" | |
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0..1 | boolean | Value of extension | |
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0..* | Extension | Reason or related clarification for off-label use. | |
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0..1 | string | Unique id for inter-element referencing | |
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0..0 | |||
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1..1 | uri | "reason" | |
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0..1 | CodeableConcept | Value of extension | |
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1..1 | uri | "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel" | |
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This structure is derived from Extension
Summary
Complex Extension: Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
Other representations of profile: CSV, Excel, Schematron
Id | Grade | Path(s) | Details | Requirements |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
offLabel-reason-required | error | Extension | If isOffLabelUse is true, reason must be provided : extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists() |